Bayer wins priority review for CKD program finerenone after PhIII data showed a delay in disease progression
Less than three months after Bayer released positive Phase III data for a top program, the FDA has agreed to take up its case.
Regulators have granted priority review for finerenone, an experimental drug in patients with chronic kidney disease and type 2 diabetes, Bayer announced Tuesday. Bayer did not unveil an expected PDUFA date but noted the FDA would likely give finerenone a typical six-month look-over.
“Based on study data, finerenone offers a potential new strategy to delay CKD progression, while reducing the risk of cardiovascular events,” Bayer CMO Michael Devoy said in a statement. “We’re encouraged that the FDA has granted the NDA a priority review.”
The decision comes following the program’s Phase III trial in which it showed a statistically significant delay in CKD, for both the disease itself and CKD related to type 2 diabetes. Looking for a sustained decrease of estimated glomerular filtration rate greater than or equal to 40% from baseline, or renal death, finerenone cut risk by 18% over a period of at least four weeks.
That amounted to a sparkling p-value of p=0.0014. Bayer also followed up on patients for a median of 2.6 years as finerenone was added to the highest-tolerated dose of standard treatment.
Bayer also hit on an important secondary endpoint, despite coming closer to missing than the primary. Finerenone reduced the risk by 14% in time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure compared to placebo, amounting to a p-value of p=0.03391.
The candidate is a non-steroidal mineralocorticoid receptor inhibitor, looking to tamp down on what researchers found is a trigger for both inflammation and fibrosis. Bayer theorized finerenone could provide more benefit in stopping fibrosis while limiting inflammation in the heart and kidneys.
Though there are quite a few CKD drugs out there, CKD patients often experience multiple drug failures due to adverse events, Indiana University School of Medicine professor Rajiv Agarwal told Endpoints News in October. While finerenone has a shorter half-life than most, allowing it to be expunged from the body more quickly, the program saw a higher rate of events related to high potassium levels, affecting 18% of the drug arm compared to half that in the control.
An approval would mark a win for the German pharma after a few tumultuous years in R&D. Bayer cut 900 R&D jobs back in November 2018 as part of a broader restructuring plan in the wake of its acquisition of Monsanto, but more recently has begun a push into gene and cell therapies. The pharma bought out AskBio for $4 billion in October and, in December, established a cell and gene therapy platform within its pharmaceuticals division in order to consolidate all of its related projects under one umbrella.